The Study of Biomarker in Early Diagnosis of GDM by Metabolomics

NCT05733195 | Unknown

• 1 other identifier: JS-3582
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Gestational Diabetes Mellitus (GDM) refers to abnormal glucose metabolism during pregnancy, in which elevated blood glucose is first found during pregnancy and meets the criteria for diabetes. In recent years, with the increase of obese women of childbearing age, the incidence of GDM has been rising, the current global average incidence is about 14%, and the incidence in China has increased from 2% in 1999 to 5%-8% at present. If one-step diagnosis is used, the rate will be between 13%-17%, which will greatly increase the social burden. Gestational diabetes mellitus (GDM) significantly increases the risk of diseases for pregnant women and infants, such as abortion and premature delivery, concurrent hypertension, concurrent infection, metabolic disorders, postpartum diabetes, macrosomia, fetal malformation, neonatal hypoglycemia, neonatal respiratory distress syndrome, and so on. It is one of the important public health problems threatening human health. Therefore, the accurate diagnosis of GDM is of great clinical significance for the timely formulation of intervention and treatment measures, reducing the risk of maternal and infant diseases and improving the level of public health.

Conditions

Gestational Diabetes Mellitus; Metabolomics Detection; Biomarker in Early Diagnosis

Keywords

GDM; Metabolomics detection; Biomarker in Early Diagnosis

Outcome Measures

Primary Outcomes (1)

• GDM（Pregnancies with gestational diabetes mellitus and no gestational diabetes）

  For pregnant women without diabetes before pregnancy, 75g glucose tolerance test (OGTT) was performed at 24-28 weeks of pregnancy as a diagnostic test. The cutting value was that the blood glucose level reached or exceeded 5.1mmol/L, 10.0mmol/L and 8.5mmol/L 0、 1 and 2 hours after taking sugar, respectively. Using standard of the International Association of Diabetes and Pregnancy Study Group (IADPSG), GDM is diagnosed with blood glucose at any point or above the above values.

  24-28weeks

Study Arms (2)

Women with GDM

All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At four time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery, and 6 weeks after delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. In the GDM group, blood samples were collected at the same time during routine visit 6 weeks after delivery. The relevant broad metabolomics and targeted vitamin profiles were also detected.

Other: OGTT test

Women with no-GDM

All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At three time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. The relevant broad metabolomics and targeted vitamin profiles were also detected.

Other: OGTT test

Interventions

OGTT test OTHER

The OGTT test (75g glucose) was performed between 24 and 28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG.

Women with GDM; Women with no-GDM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnancies with gestational diabetes mellitus and no gestational diabetes

You may qualify if:

• First trimester (6-13 weeks)；Pregnant women with a singleton pregnancy；Pregnant women who are registered at the hospital and have regular antenatal check-ups；Pregnant women who volunteered for the study were required to sign an informed consent form

You may not qualify if:

• Pregnant women with known type 1 or type 2 diabetes mellitus；Pregnant women with hyperlipidemia and hyperbilirubinemia；Pregnant women with hepatic and renal insufficiency

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 17, 2023
• Study Start: May 4, 2022
• Primary Completion: August 30, 2023
• Study Completion: May 30, 2024
• Last Updated: February 17, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)